A novel technique for transforming the theft of mortal human cells into praiseworthy federal policy.
A revolution has occurred in the attitude of biologists toward their intellectual property rights. What today is patentable and highly profitable was, 20 years ago, unpatentable and given away for nothing. The history of this revolution began in the early 1960s when we made the first effort to have self-duplicating cell strains patented. The application was denied because patent law at that time did not include living matter. Because of the demand for our normal human diploid cell strain, WI-38, by NIH grantees, NIH support was provided to distribute WI-38 gratis to hundreds of recipients. These included vaccine and cell manufacturers who profited enormously from the direct sale of WI-38 or its use as a substrate for many human virus vaccines. When federal support for the distribution of WI-38 ended, but demand did not, I continued to distribute it for costs similar to those made by the American Type Culture Collection. When I took the first initiative and asked NIH to have the then unique question of title to a self-duplicating system resolved, they sent an accountant who accused me of theft of government property. I replied with a lawsuit that, after six years of litigation, we won with an out-of-court settlement. During these six years the United States Supreme Court ruled that living matter could be patented. Also, the biotechnology industry was launched by biologists who, like me, started companies using cells or microorganisms developed with federal support. This use of intellectual property rights by the nascent biotechnology industry was ultimately embraced by the entire biological community and by a directive from the President of the United States. This revolution has now evolved to the point where government biologists themselves may profit from research in federal laboratories, and the NIH itself aggressively seeks private commercial alliances. Universities have also pursued similar alliances to the extent that today the distinction between a research university and a commercial organization is only in the eyes of the Internal Revenue Service.
Hayflick
L
L
Department of Anatomy, University of California, San Francisco, USA. len@gene.com
D001709:Biotechnology / Q000331:legislation & jurisprudence*; D016923:Cell Death; D002460:Cell Line; D006801:Humans; D018973:Intellectual Property; D009316:National Institutes of Health (U.S.); D010330:Patents as Topic; D011640:Public Policy; D013800:Theft; D014481:United States